FDA User Fee Legislation Extended

Jul 09, 2012

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President Obama on July 9 signed the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187), reauthorizing fees collected by the FDA from medical device and pharmaceutical companies to fund the approval process.

The bill landed on the President's desk after passing through the Senate and House in late June. “Quickly getting the latest devices and prescription drugs to patients who need them is critical to our nation’s health,” said ACC President William Zoghbi, MD, FACC, following the Senate vote. “Members of the House and Senate demonstrated that they can come together in a bipartisan way to approve a measure that will support innovation and safety in health care.”

“Innovative treatments have played a pivotal role in reducing deaths due to cardiovascular disease in recent decades,” Zoghbi continued. “It is important to support a system that facilitates the safe adoption of new medications and devices. The College commends Congress for taking steps to improve post market surveillance of medical devices and increase the use of data registries to improve patient care and device safety. We hope President Obama will act quickly to sign the FDA User Fee Bill.”

Earlier in the summer, committee staff from both chambers ironed out differences between the House and Senate versions of the bill, landing on final legislation. On May 30, the House overwhelmingly passed its version of the the bill (H.R. 5651) in a vote of 387 to 5. The Senate passed its version of the bill (S. 3187) by a vote of 96 to 1 on May 24.

ACC advocacy staff worked closely with House and Senate Committee staff throughout the process. (Read a letter sent May 7 to Energy and Commerce Committee leaders). The College supported provisions in the bills that addressed device registries, increased postmarket surveillance, and the expansion of sentinel to medical devices included in the final bill.